Overview

India Bengaluru - hybrid/Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

The Medical Officer has functional responsibility for medical monitoring of clinical trials, medical reviewing of activities and for broad spectrum of internal and external medical consulting, including, but not limited to, advising related to protocol development, preparation of medical strategy for feasibility studies, involvement in bid preparation and bid defense meetings, delivery of medical trainings for relevant stakeholders, professional engagement with external clinical experts, etc.

Responsibilities

Works directly with the Head of Pharmacovigilance and Medical Monitoring, in managing both corporate and project-related activities. Cooperates directly with Safety Monitors, Project Leadership, Data Managers and other relevant functional groups.
At the project level, will function in the role of a Medical Monitor leading the clinical trial monitoring of safety and efficacy data for the assigned protocols in scope of the contract with the client and in compliance with relevant SOP and/or other relevant study specific documents.
Provides safety oversight throughout the lifecycle of the clinical study including evaluation, assessment, and monitoring of safety events and protocol deviations.
Cooperates with Safety Monitors to implement safety management activities and achieve study project objectives.
Evaluates adverse events, serious adverse events (SAE) including expedited reporting, as well as other protocol defined safety events.
Reviews SAE narratives and other safety reports.
Reviews IND/IDE safety reports (MedWatch safety reports, FDA Form 3500A), Council for International Organizations of Medical Sciences (CIOMS) safety reports, Development Safety Update Reports (DSUR), and other aggregate reports as applicable.
Reviews and approves Medical Dictionary for Regulatory Activities (MedDRA) and WHO Drug coding.
Reviews the FDA MedWatch Alerts, safety communications and/or other communications from other relevant Regulatory Authorities and recommends action for implementation by study teams, as applicable.
Provides medical input during development of protocol and associated documents – in scope agreed with the client, primarily focusing on the safety aspect of the clinical development.
Advises study sponsor and study team on protocol development, inclusion/exclusion criteria, eligibility questions, protocol study design and halting rules, etc.
Per agreement with client ensures the medical and scientific quality of safety sections of documents such as clinical trial protocols, investigator’s brochure, informed consent document, patient diaries, and case report forms.
Works directly with project-level staff to develop appropriate study documents and project plans (e.g., Safety Monitoring Plan, Medical Monitoring Plan, Communication Plan, and Training Plan).
Supports preparation of safety section of clinical trial reports such as annual reports and clinical study reports.
Engages with safety oversight committees (SOC) and consults with sponsors, investigators, and pharmaceutical partners, as appropriate.
Participates in safety oversight committee meetings (DSMB/DMC/SMC); answers questions about safety monitoring and related procedures (e.g., review of halting rules).
Reviews SOC Charter, safety reports, and meeting minutes.
Participates in sponsor meetings and investigator training meetings.
Participates in regulatory (FDA or other) meetings and scientific review meetings.
Interacts with pharmaceutical companies and other study partners.
Cooperates with business development teams as medical expert, participates in bid preparation and bid presentations.
Acts as the internal medical consultant in broad spectrum of activities, e.g., prepares medical strategy for the feasibility activities and proposal of country mix, ensures relevant medical training for the assigned project staff, engages with identified external consultants to gain information from clinical practice, etc.
If contracted with client and if relevant to level of own medical expertise, Medical Officer provides broad spectrum of medical consultancy services, including medical review of relevant documents and/or data (e.g., clinical study specific documents, clinical study report, training materials, scientific communication or communication materials with medical content, etc.).
Participates in corporate process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT) processes, SOP development, participation in internal and external audits, and professional development activities.
Other corporate activities include annual SOP reviews, participation in corporate safety meetings/activities, and other relevant corporate activities.

Qualifications

Medical Doctor (MD, MBBS, MBBCh, or other equivalent) degree is required.
2 years of working experience, preferably a combination of clinical practice and experience in the area of pharmaceutical medicine (i.e., clinical research, pharmacovigilance, medical affairs, regulatory etc.).
Demonstrated clinical medicine expertise through practice experience preferred.
Excellent clinical judgement and ability to communicate complex clinical issues in a scientifically sound and understandable way.
Experience working with regulatory submissions.
Expertise in safety and/or medical monitoring and serious adverse event reporting preferred.
Demonstrated experience with or training in clinical trial data collection.
Ability to work as a team member and function on a cross-functional team.
Ability to direct activities and encourage positive team-based culture.
Capacity to provide leadership and creativity in the work environment.
Excellent verbal and written communication skills.

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